medical device guru

FDA Keeps Contraceptive on Market After it Makes Women Sick

Last month, Food and Drug Administration Commissioner Scott Gottlieb met with a group of women who’ve been knocking on the agency’s door for years.

Online, they’re known as E-sisters: women who were implanted with the permanent “non-incisional” contraceptive called Essure, which consists of metal coils that are implanted into the fallopian tubes and contain nickel. The E-sisters believe Essure has caused them ― and tens of thousands of others ― a constellation of health problems, from bleeding, bloating and pelvic pain to more obscure symptoms like rashes, tooth loss, joint pain and fatigue associated with an allergic or autoimmune reaction.

The women asked the commissioner to take Essure off the market. They brought with them a large photo album of sister sufferers and their grisly symptoms. They also brought Madris Tomes, a former FDA analyst who launched her own software company to better track adverse events reported to the agency. These are public files, but are not easily searchable by the public or even the FDA, according to Tomes. She told Gottlieb she had logged more than 26,000 reports about Essure to date, including eight adult deaths. At the time, the FDA told BuzzFeed News it was still counting reports from 2017.

Search our current open opportunities to take your first step to success in Medical Device and Healthcare IT today. Focusing on you and your career is our Job, now it’s time for you to find yours. Let’s get started.